Cyclobenzaprine treatment for agitation, psychosis and cognitive decline in dementia and neurodegenerative conditions

Abstract

Compositions comprising cyclobenzaprine, and methods for the treatment or prevention of agitation, psychosis and/or cognitive decline and associated symptoms thereof in dementia and other neurodegenerative conditions.

The invention claimed is: 
     
       1. A method for treating or preventing one or more agitation associated symptoms of dementia, the agitation associated symptoms being selected from the group consisting of rapid changes in mood, rapid changes in irritability, rapid changes in outbursts, delusions, hallucinations, checking and rechecking doors or appliances, tearing tissues, uncharacteristic cursing or threatening language, delirium, aggression, verbal aggression, physical aggression, combativeness, lability of mood, anger, akathisia, compulsions, obsessivity, impairment of interpersonal relationships, impairment of social functioning, impairment to perform or participate in daily living activities, and urinary incontinence, the method comprising administering to a subject in need or at risk thereof, a pharmaceutical composition comprising a eutectic of cyclobenzaprine HCl and mannitol and a pharmaceutically acceptable carrier, the composition providing 5.6 mg or less per day of the cyclobenzaprine HCl to said subject. 
     
     
       2. The method of  claim 1 , wherein the pharmaceutical composition is administered daily. 
     
     
       3. The method of  claim 2 , wherein the composition comprises cyclobenzaprine HCl in an amount of
 (a) less than 5 mg; 
 (b) 5.6 mg; or 
 (c) 2.8 mg. 
 
     
     
       4. The method of  claim 3 , wherein the composition is administered simultaneously as two dosage units, wherein each dosage unit comprises 2.8 mg of cyclobenzaprine HCl or wherein the combined amount in the two dosage units is 5.6 mg of cyclobenzaprine HCl. 
     
     
       5. The method of any one of  claims 1 ,  4 ,  2  and  4 , wherein the composition is administered once daily. 
     
     
       6. The method of  claim 1 , wherein the pharmaceutical composition is in a dosage form selected from a tablet, a scored tablet, a coated tablet, an orally dissolving tablet, a suppository, a thin film, a powder, a caplet, a capsule, a troche, a dragee, a dispersion, a suspension, a solution, or a patch. 
     
     
       7. The method of  claim 1 , wherein the pharmaceutical composition is administered sublingually, buccally, orally, intravenously, intramuscularly, subcutaneously, inhalationally, intranasally, transdermally, parenterally, rectally, or vaginally.